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Amino Acid Blend

Amino Acid Blend for Delirium

N/A
Recruiting
Led By Gohar Azhar, M.D.
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Delirious cohort: Aged 60 years and older. Documented presence of either delirium, acute confusion, or altered mental status in medical record. Currently hospitalized with a diagnosis of sepsis/septicemia, pneumonia, urinary tract infection, Clostridium-difficile infection, other bone or tissue infection, or fever of unknown origin
Be older than 18 years old
Must not have
Chronic kidney disease (eGFR <30)
Admitted to the hospital for major psychiatric illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up as determined over an up to 4-day intervention duration.

Summary

This trialwill test if a blend of amino acids can help prevent delirium in older people in hospital with infections. 45 people will drink either the blend or a placebo.

Who is the study for?
This trial is for hospitalized individuals aged 60 or older with delirium due to infections like sepsis, pneumonia, UTI, bone/tissue infection, or fever of unknown origin. It excludes those with chronic kidney disease, recent major surgery, uncontrolled psychiatric illness, suspected COVID-19, and delirium from substance withdrawal.
What is being tested?
The study tests a special amino acid blend thought to prevent or lessen delirium severity against a placebo (sugar water). Of the up to 45 participants enrolled: 15 will take the blend twice daily for four days; another 15 will have the placebo; and the remaining are non-delirious controls not consuming any product.
What are the potential side effects?
Potential side effects aren't specified but may include reactions typical of nutritional supplements such as gastrointestinal discomfort. Since it's an amino acid blend designed for elderly patients, risks are likely minimal compared to pharmaceutical drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 60 or older, currently hospitalized with an infection or fever, and have experienced confusion or altered mental status.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is severely reduced.
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I have been hospitalized for a serious mental health issue.
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My mental health condition is well-managed with medication or treatment.
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I have or might have COVID-19.
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I have not had major surgery in the last 5 days.
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I use a feeding tube all the time.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~as determined over an up to 4-day intervention duration.
This trial's timeline: 3 weeks for screening, Varies for treatment, and as determined over an up to 4-day intervention duration. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in CAM-S (Confusion Assessment Method-Short) score from baseline to day 3 or up to day 4.

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Non-delirious control subjects who receive no interventionActive Control1 Intervention
Subjects receive no intervention and are observed for 2-3 days.
Group II: Delirious subjects receiving active study productActive Control1 Intervention
Subjects will ingest an oral amino-acid containing nutritional supplement twice daily for up to 4 days.
Group III: Delirious subjects receiving placeboPlacebo Group1 Intervention
Subjects will ingest a flavored, sweetened, inactive drink twice daily for up to 4 days.

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
496 Previous Clinical Trials
150,346 Total Patients Enrolled
Gohar Azhar, M.D.Principal InvestigatorUniversity of Arkansas
1 Previous Clinical Trials
21 Total Patients Enrolled

Media Library

260279 active study product (Amino Acid Blend) Clinical Trial Eligibility Overview. Trial Name: NCT05066503 — N/A
Confusion Research Study Groups: Delirious subjects receiving placebo, Non-delirious control subjects who receive no intervention, Delirious subjects receiving active study product
Confusion Clinical Trial 2023: 260279 active study product Highlights & Side Effects. Trial Name: NCT05066503 — N/A
260279 active study product (Amino Acid Blend) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05066503 — N/A
~9 spots leftby Jan 2026
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